Removable fallopian tube plug and associated methods

ABSTRACT

A removable fallopian tube plug includes an elongated shaft member that has a diameter dimensioned for insertion into a human fallopian tube. The shaft has an imagable portion located at each of a distal end and a proximal end. A plurality of flexible fingerlike protrusions are affixed to at least a portion of the shaft, and are movable between a first position generally adjacent the shaft and a second position extending radially outward therefrom. The protrusions are biased to the second position and are adapted for closely engaging the fallopian tube when in the second position, and they are further arrayed radially and axially so as to form a barrier sufficient to prevent a passage of an ovum or a spermatozoa in an axial direction.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to devices for blocking a bodily passage,and, more particularly, to such devices for removably blocking afallopian tube.

2. Description of Related Art

Sterilization remains the most popular contraceptive method in theUnited States, particularly among women, with approximately 40% of allmen and women combined relying on sterilization as a contraceptivemethod. Based upon 1988 date, approximately 600,000-700,000 femalesterilizations are performed each year in the United States, with about50% of these comprising postpartum tubal ligations via minilaparotomy.

Safe, nonpermanent physical methods of contraception are desirable forwomen who do not wish to or cannot take contraceptive medication. Sincethe intrauterine device (IUD) has been largely removed from the U.S.market, efforts have been expended to devise an effective fallopian tubeplug to prevent the passage of an ovum into the uterus or of aspermatozoa toward an ovary.

Among the devices that have been disclosed are the fallopian tube plugof Heltebrandt et al. (U.K. Pat. Appl. GB 2 010 728 A), the plug andclip device of Roth et al. (U.S. Pat. No. 4,523,590), and the tubularpessary of Hamou (U.S. Pat. No. 4,579,110).

Over the past several years higher-quality flexible hysteroscopes havingoperating channels have become available, along with improved optics. Itis believed that such devices can contribute to the development of analternative reversible contraceptive method.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a device and methodfor blocking a fallopian tube.

It is an additional object to provide such a device that is removable.

It is a further object to provide such a device that is minimallyinvasive.

It is another object to provide such a device that is imagable toprovide localization.

It is yet an additional object to provide such a device that does notcause scarification of the fallopian tube.

It is yet a further object to provide a reversible method for blocking afallopian tube.

It is yet another object to provide such a method that can be performedon an out-patient basis with little or no anaesthesia.

An additional object is to provide a method of making a fallopian tubeplug.

These objects and others are attained by the present invention, aremovable fallopian tube plug that comprises an elongated shaft memberthat has a diameter dimensioned for insertion into a human fallopiantube. The shaft has an imagable portion located at least at each of adistal end and a proximal end.

A plurality of flexible fingerlike protrusions are affixed to at least aportion of the shaft, and are movable between a first position generallyadjacent the shaft and a second position extending radially outwardtherefrom. The protrusions are biased to the second position and areadapted for closely engaging the fallopian tube. Further, theprotrusions are arrayed radially and axially so as to form a barriersufficient to prevent a passage of an ovum or of a spermatozoa in anaxial direction.

It is preferred that the plug also comprise means for being grippedlocated at the proximal end in order to facilitate insertion andremoval.

One of the methods of the present invention, for blocking a fallopiantube, includes grasping the plug as described above at a proximal end.The plug is then inserted through the cervix and into the ostium. Theprotrusions are dimensioned so as to be moved toward the first positionduring insertion into the tube, and then to be permitted to move towardthe second position when insertion is complete, to closely engage thefallopian tube wall. Finally, the plug's proximal end is released, andthe plug is permitted to remain within the tube until and if removal isdesired.

The features that characterize the invention, both as to organizationand method of operation, together with further objects and advantagesthereof, will be better understood from the following description usedin conjunction with the accompanying drawing. It is to be expresslyunderstood that the drawing is for the purpose of illustration anddescription and is not intended as a definition of the limits of theinvention. These and other objects attained, and advantages offered, bythe present invention will become more fully apparent as the descriptionthat now follows is read in conjunction with the accompanying drawing.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side perspective view of a first embodiment of the fallopiantube plug of the present invention.

FIG. 2 is an end (axial) view of the first embodiment.

FIG. 3 is a side perspective view of a second embodiment of thefallopian tube plug of the present invention.

FIG. 4 is an end (axial) view of the second embodiment.

FIG. 5 illustrates a first method of inserting the fallopian tube plug,including: (A) grasping the plug with an insertion device; (B) passingthe plug and distal end of the insertion device into the ostium; (C)releasing the plug from the insertion device; and (D) withdrawing theinsertion device, leaving the plug within the fallopian tube.

FIG. 6 illustrates a second method of inserting the fallopian tube plug,including (A) obtaining a hysterosalpingogram; (B) inserting a secondcatheter and injecting contrast material; (C) removing second catheterand inserting a plug; and (D) injecting additional contrast medium todetermine tubal occlusion.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

A description of the preferred embodiments of the present invention willnow be presented with reference to FIGS. 1-6D.

A first embodiment 10 of a fallopian tube plug is illustrated in FIGS. 1and 2. The plug 10 comprises a shaft 11 that in turn comprises arelatively rigid rod 12 comprising a material that is imagable, such as,for example, by x-rays or ultrasound. This permits a noninvasivelocalization of the plug 10. An exemplary rod material comprises a metalsuch as stainless steel, although this is not intended as a limitation.

The shaft 11 further comprises a coating layer 14 that envelopes thecore 12. The coating layer 14 comprises a biocompatible material such asa polymeric material. Exemplary polymeric materials comprisepolytetrafluoroethylene and nylon, although these are not intended aslimitations. In an alternate embodiment, the coating layer 14 comprisesa compressible material with memory, such as a foamlike material.

The plug 10 additionally comprises a plurality of fingerlike protrusions16 that are coformed with the coating layer 14. The preferred polymericmaterial is believed to be beneficial owing to its inert and atraumaticcharacteristics. Their being integrally formed with the coating layer 14significantly lessens the chance of breaking off and remaining in thetube after removal of the plug 10.

The protrusions 16 are formed along at least a portion of the shaft 11,and are movable between a first position generally adjacent the shaft 11and a second position extending radially outward from the shaft 11. Theprotrusions 16 are biased to the second position and are adapted forclosely engaging the fallopian tube.

The protrusions 16 are arrayed radially and axially so as to form abarrier sufficient to prevent a passage of an ovum or a spermatozoa inan axial direction (see FIG. 2). In this embodiment the protrusions 16are arrayed in a plurality of axially spaced-apart rows 17, such thateach protrusion 16 in a row 17 is radially offset from an adjacentprotrusion 16' in an adjacent row 17'. Thus in viewing the plug 10 alongan axial direction the protrusions 16 would be seen to present a fullyoccluded appearance, which would serve to prevent the passage of an ovumor a spermatozoa thereby.

The plug 10 also comprises a grip knob 18 at the proximal end 102 thatfacilitates insertion and removal of the plug 10. Typically in use theplug 10 is inserted and removed with the use of an insertion device,such as, but not intended to be limited to, a flexible-tip-typehysterofiberscope 30 (see FIGS. 5A-5D). This instrument has a pair ofmovable jaws 31 that can grip and lock on the knob 18 during theinsertion and removal processes. Alternatively, or a forceps F may beused, as in FIGS. 6A-6D.

In a second embodiment (FIGS. 3 and 4), a fallopian tube plug 20comprises a shaft 21 that in turn comprises a relatively rigid rod 22comprising a biocompatible material such as a polymeric material. Asabove, exemplary polymeric materials comprise polytetrafluoroethyleneand nylon, although these are not intended as limitations.

The shaft 21 further comprises a pair of locators 23, 23' that areembedded in the rod 22 adjacent the distal 201 and proximal 202 ends,respectively. The locator material should be imagable, such as, forexample, by x-rays, ultrasound, or hysterosalpingogram, again permittinga noninvasive localization of the plug 20. An exemplary locator materialcomprises a metal such as stainless steel, although this is not intendedas a limitation.

The plug 20 additionally comprises a plurality of fingerlike protrusions26 that are coformed with the rod 22. Again, a polymeric material suchas polytetrafluoroethylene or nylon is believed to be beneficial owingto its inert and atraumatic characteristics. Their being integrallyformed with the rod 22 significantly lessens the chance of breaking offand remaining in the tube after removal of the plug 20.

As with the first embodiment, the protrusions 26 are formed along atleast a portion of the shaft 21, and are movable between a firstposition generally adjacent the shaft 21 and a second position extendingradially outward from the shaft 21. The protrusions 26 are biased to thesecond position and are adapted for closely engaging the fallopian tube.

The protrusions 26 are arrayed radially and axially so as to form abarrier sufficient to prevent a passage of an ovum or a spermatozoa inan axial direction (see FIG. 4). In this embodiment the protrusions 26are arrayed in generally helical fashion, so that each protrusion 26 isradially and axially offset from an adjacent protrusion 26'. Thus inviewing the plug 20 along an axial direction the protrusions 26 would beseen to present a fully occluded appearance, which would serve toprevent the passage of an ovum or a spermatozoa thereby.

The plug 20 also comprises a grip knob 28 at the proximal end 202 thatfacilitates insertion and removal of the plug 20.

One preferred embodiment of a method of inserting either of the plugs10,20 as described above (FIGS. 5A-5D) comprises the steps of creatingan access into the uterus U and fallopian tube FT such as by means wellknown in the art, typically including inserting a speculum into thevagina V and sterilizing with a solution such as Betadine. In somepatients one or both of the steps of effecting a paracervical block,such as by using a 1% lidocaine solution with epinephrine, andperforming a dilatation of the cervix C may be necessary or desired.

A flexible hysteroscope H, preferably of the type includingvisualization means such as fiber optic illumination and viewingelements, is employed as an insertion device. Such a device thatfulfills these requirements includes, but is not intended to be limitedto, a hysterofiberscope "HYF_(TYPE) 1T" (Olympus, Lake Success, N.Y.),having an outside diameter appropriate for such an application, such as4.9 mm.

The hysteroscope H is inserted through the cervical os COS using aphysiologic saline solution such as intravenous fluid as a uterinedistension medium. A blood pressure cuff pressurized, for example, at150 mmHg or a 30-60 cc syringe may be employed to increase in-linepressure.

A forceps-type grasper G inserted through the distal end of the scope His used to grasp the plug 10 or 20 at the proximal end 102,202 (FIG.5A). The plug 10 or 20 is then inserted into the ostium OS to a desiredlocation within the tube FT (FIG. 5B). The plug 10 or 20 is then pulledproximally slightly in order to fully deploy the protrusions 16,26toward the second position to closely engage the fallopian tube wall.Next the plug's proximal end 102,202 is released from the forceps (FIG.5C), and the scope H is removed, leaving the plug 10,20 in place (FIG.5D).

Typically the plug insertion steps are repeated to insert a second plug10,20 into the contralateral side's fallopian tube FT'.

Preferably a test should be performed to ensure that occlusion of thetube has been achieved. Such a test may include, for example, attemptingto pass air bubbles in a solution past the plugs.

The plug(s) 10,20 can be localized after insertion by imaging, such asby x-radiography or ultrasound, owing to the presence of the imagableportions at the proximal 102,202 and distal 101,201 ends.

A second method of performing fallopian tube FT occlusion comprises thesteps of creating an access into the uterus U as above, and determininga patent fluid pathway such as, for example, by hysterosalpingography,wherein radio-opaque fluid material is injected through a first catheter40 into the uterus U and a visualization of the area provides anindication as to the patency or occlusion of the fallopian tubes FT andto determine the position of the cornu CO (FIG. 6A).

A second cathether 41, which is narrower than the first catheter 40, andfurther is curved, is inserted through the first catheter 40 and wedgedinto the cornual angle CA. Further contrast material is inserted throughthe second catheter 41 to determine the patency of this region (FIG.6B). Exemplary catheters 40,41 usable in this procedure may comprise,but are not intended to be limited to, coaxial catheters 9 F and 5.5 F,respectively.

The second catheter 41 is removed, and the distal end of a graspingforceps F, having been used to grasp the tube plug's knob 18, is placedthrough the first catheter 40, to position a plug 10 (FIG. 6C). Theforceps F are removed, and the procedure of FIGS. 6B and 6C are repeatedif desired contralaterally.

Additional contrast medium is injected to determine if the tubalocclusion were successful (FIG. 6D). If not, the procedure is repeated,with the tubal plug 10 being wedged more tightly until full occlusion isachieved.

The tubal occlusion methods of the present invention are believed torepresent procedures easily performed in an office setting, on anoutpatient basis, without general anaesthesia. It is believed that arelatively small dose of a relaxant (such as Valium) and/oranti-inflammatory (such as a nonsteroidal anti-inflammatory drug) issufficient medication under which to perform the procedures.

It may be appreciated by one skilled in the art that additionalembodiments may be contemplated, including alternate materials andalternate arrangements of the occluding protrusions.

In the foregoing description, certain terms have been used for brevity,clarity, and understanding, but no unnecessary limitations are to beimplied therefrom beyond the requirements of the prior art, because suchwords are used for description purposes herein and are intended to bebroadly construed. Moreover, the embodiments of the apparatusillustrated and described herein are by way of example, and the scope ofthe invention is not limited to the exact details of construction.

Having now described the invention, the construction, the operation anduse of preferred embodiment thereof, and the advantageous new and usefulresults obtained thereby, the new and useful constructions, andreasonable mechanical equivalents thereof obvious to those skilled inthe art, are set forth in the appended claims.

What is claimed is:
 1. A removable fallopian tube plug comprising:anelongated shaft member having a diameter dimensioned for insertion intoa human fallopian tube, the shaft comprising a core comprising a rigid,imagable rod and a coating layer enveloping the core comprising apolymeric material; and a plurality of flexible finger protrusionsaffixed to at least a portion of the shaft, the protrusions movablebetween a first position generally adjacent the shaft and a secondposition extending radially outward therefrom, the protrusions biased tothe second position and adapted for closely engaging the fallopian tube,the protrusions further arrayed radially and axially so as to form abarrier sufficient to prevent a passage of an ovum or a spermatozoa inan axial direction.
 2. The fallopian tube plug recited in claim 1,wherein the protrusions and the coating layer are co-formed from thepolymeric material.
 3. The fallopian tube plug recited in claim 1,wherein the polymeric material is selected from a group consisting ofpolytetrafluoroethylene, nylon, and a compressible foam.
 4. Thefallopian tube plug recited in claim 1, wherein the rod comprises ametal.
 5. The fallopian tube plug recited in claim 4, wherein the metalcomprises stainless steel.
 6. A removable fallopian tube plugcomprising:an elongated shaft member having a diameter dimensioned forinsertion into a human fallopian tube, the shaft comprising a generallyrigid rod having an imagable material affixed at a distal end and at aproximal end; and a plurality of flexible finger protrusions affixed toat least a portion of the shaft, the protrusions movable between a firstposition generally adjacent the shaft and a second position extendingradially outward therefrom, the protrusions biased to the secondposition and adapted for closely engaging the fallopian tube, theprotrusions further arrayed radially and axially so as to form a barriersufficient to prevent a passage of an ovum or a spermatozoa in an axialdirection.
 7. The fallopian tube plug recited in claim 6, wherein therod comprises a polymeric material and the imagable material comprises ametal embedded in the rod adjacent the distal end and adjacent theproximal end.
 8. The fallopian tube plug recited in claim 7, wherein theprotrusions and the rod are co-formed from the polymeric material.
 9. Amethod for blocking a fallopian tube comprising the steps of:grasping afallopian tube plug at a proximal end, the plug comprising:an elongatedshaft member having a diameter dimensioned for insertion into a humanfallopian tube, the shaft having an imagable portion located at each ofa distal end and the proximal end; and a plurality of flexible fingerprotrusions affixed to at least a portion of the shaft, the protrusionsmovable between a first position generally adjacent the shaft and asecond position extending radially outward therefrom, the protrusionsbiased to the second position and adapted for closely engaging thefallopian tube, the protrusions further arrayed radially and axially soas to form a barrier sufficient to prevent a passage of an ovum or aspermatozoa in an axial direction; inserting the plug through the cervixand into the ostium, the protrusions moving toward the second positionto closely engage the fallopian tube wall; releasing the plug proximalend; and permitting the plug to remain within the fallopian tube.
 10. Amethod for blocking a fallopian tube comprising the steps of:determininga patency of a fallopian tube; wedging a catheter into a cornual angleof the fallopian tube; determining a patency of the fallopian tube withthe catheter wedged therein; removing the catheter; grasping a fallopiantube plug at a proximal end, the plug comprising:an elongated shaftmember having a diameter dimensioned for insertion into a humanfallopian tube, the shaft having an imagable portion located at each ofa distal end and the proximal end; and a plurality of flexible fingerprotrusions affixed to at least a portion of the shaft, the protrusionsmovable between a first position generally adjacent the shaft and asecond position extending radially outward therefrom, the protrusionsbiased to the second position and adapted for closely engaging thefallopian tube, the protrusions further arrayed radially and axially soas to form a barrier sufficient to prevent a passage of an ovum or aspermatozoa in an axial direction; inserting the plug through the cervixand into the ostium, the protrusions moving toward the second positionto closely engage the fallopian tube wall; releasing the plug proximalend; and permitting the plug to remain within the fallopian tube. 11.The method recited in claim 10, wherein the patency determining stepseach comprise performing a hysterosalpingogram.
 12. The method recitedin claim 10, further comprising the step, following the step ofpermitting the plug to remain within the fallopian tube, ofredetermining fallopian tube patency.
 13. The method recited in claim10, further comprising repeating the steps thereof for a contralateralfallopian tube.